BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR

    MDR report key: 1111723 · Received August 14, 2008

    Report

    Report Number
    1033553-2008-00093
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 13, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    PO40045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT CONTACTED VISTAKON VIA EMAIL JULY 16, 2007. THE PT REPORTED BEING DIAGNOSED WITH A CORNEAL ULCER IN THE LEFT EYE IN 2008 AFTER BEING PLACED IN ACUVUE OASYS PRODUCT. THE PT WAS UTILIZING A DAILY WEAR SCHEDULE. THE PT REPORTED THE, "ULCER QUICKLY HEALED USING ZYMAR ANTIBIOTIC DROPS." THE PT ALSO INDICATED, "I BECAME MORE METICULOUS THAN EVER CHANGING MY SOLUTION ETC AND WORE GLASSES FREQUENTLY. THE CORNEAL ULCER RECURRED IN EARLY JULY. THIS TIME AROUND, AFTER A WEEK STILL NO PROGRESS USING VIGAMOX DROPS AND WEARING GLASSES." MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE TREATING OPHTHALMOLOGIST'S CONTACT DETAILS AND TO OBTAIN THE LOT NUMBER AND ARRANGE FOR THE RETURN OF THE PRODUCT IN QUESTION. THE PT DID NOT PROVIDE THE INFO. BECAUSE A "CORNEAL ULCER" MAY OR MAY NOT BE A SERIOUS INJURY IN ACCORDANCE WITH THE SERIOUS INJURY DETERMINATION FORM THIS EVENT IS BEING REPORTED AS WORST CASE. BASED ON THE LIMITED INFO RECEIVED, THIS INJURY WILL BE REPORTED AS A SERIOUS INJURY AS A WORST CASE. WILL PROVIDE ANY ADD'L INFO RECEIVED WITHIN 30 DAYS SHOULD ADD'L INFO BE RECEIVED. ALL REPORTABLE ADVERSE EVENTS ARE REVIEWED DURING QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention